The COAPT trial investigated MitraClip for treating secondary MR, a type of MR in which the damaged left ventricle of the heart – often due to a heart attack or other cause of heart failure – impairs the performance of a normal mitral valve. The COAPT data add to more than 10 years of evidence on the use of MitraClip for treating primary MR, and now provide randomized trial evidence supporting MitraClip as a possible option to treat secondary MR. It's estimated that two to three times as many patients may benefit from MitraClip treatment for secondary MR as a result of underlying heart failure, than those treated now for the primary form of the disease commonly associated with age.5
People with heart failure may develop secondary MR when the left chamber of the heart becomes enlarged, preventing the mitral leaflets from closing.6 Significant secondary MR is difficult to manage, is associated with a poor prognosis,7 and can lead to reduced quality of life, recurrent hospitalizations and decreased survival.8,9 While there are currently no FDA-approved devices for secondary MR, guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy (CRT, a heart failure treatment that keeps the right and left ventricles pumping in sync) may provide symptomatic relief in some patients.10
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Most heart failure patients with clinically significant secondary MR are treated with medication only and have few treatment options.11 The COAPT study aimed to assess the safety and efficacy of MitraClip treatment for heart failure patients with clinically significant secondary MR who remained symptomatic despite receiving optimal medical therapy.
Key results from the trial include:
Treatment with MitraClip plus medical therapy resulted in a statistically significant reduction in heart failure hospitalization through two years compared to medical therapy alone (annualized rate of 67.9 percent per year vs. 35.8 percent per year; p<0.001).
MitraClip treatment reduced all-cause mortality through two years, from 46.1 percent of patients in the control group to 29.1 percent in the device group at two years of follow-up (p<0.001).
At one year, freedom from device-related complications was 96.6 percent, exceeding the performance goal for the primary safety endpoint (p<0.001).
Patients in the device group experienced significant reduction in MR severity (at one year, MR < 2+ was present in 94.8 percent of patients in the device group and in 46.9 percent of patients in the control group; p<0.001) and NYHA class (at one year, NYHA class I or II was present in 72.2 percent of patients in the device group and in 49.6 percent of patients in the control group; p<0.001).
